Drug Landscape ›
Evening Primrose Oil ›
Regulatory · United States
Marketing authorisation
FDA
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Window: 20 April 2025 – 20 April 2026
Total reports: 949
Most-reported reactions
Fatigue — 139 reports (14.65%) Nausea — 128 reports (13.49%) Headache — 119 reports (12.54%) Dizziness — 100 reports (10.54%) Pain — 83 reports (8.75%) Arthralgia — 82 reports (8.64%) Malaise — 79 reports (8.32%) Diarrhoea — 77 reports (8.11%) Drug Ineffective — 72 reports (7.59%) Pain In Extremity — 70 reports (7.38%)
Source database →
Evening Primrose Oil in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Evening Primrose Oil approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Evening Primrose Oil in United States?
Medical College and Hospital Kolkata is the originator. The local marketing authorisation holder may differ — check the official source linked above.